The FDA is urging Primus Pharmaceuticals, a Scottsdale, Ariz.-based drugmaker, to voluntarily recall its osteoarthritis product Limbrel due to increased reports of adverse events following prolonged use of the product.
In November, the FDA issued a warning to consumers telling them to immediately stop taking Limbrel until the agency completed an investigation into the reported rise of adverse events, such as drug-induced liver injury and hypersensitivity pneumonitis, a lung condition.
As of Nov. 21, the FDA received 194 reports of adverse events involving Limbrel. In a preliminary investigation, 30 of the events were found to be associated with the product. Since issuing that public warning on Nov. 21, the agency has received additional reports of liver and lung injuries in connection to the product.
Although Primus markets Limbrel as a medical food, since it is supposed to "address the metabolic process associated with osteoarthritis," the FDA is now calling the product an "unapproved drug." The agency can not force the company to recall the product.